Ex Parte Sigrist et al

Patent Trial and Appeal Board

Sep 23, 2016

12969664 (P.T.A.B. Sep. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/969,664 12/16/2010 Reto Sigrist
67491 7590 09/27/2016
DINSMORE & SHOHL, LLP
FIFTH THIRD CENTER
ONE SOUTH MAIN STREET
SUITE 1300
DAYTON, OH 45402
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO.
ROJ 0097 PA/26351
US-REA
CONFIRMATION NO.
4659
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
09/27/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
daytonipdocket@dinsmore.com
pair_roche@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RETO SIGRIST, NICOLE BERNINI, and AXEL REMDE
Appeal2014-009039
Application 12/969,664
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL 1
This is an appeal under 35 U.S.C. § 134 involving claims 1---6, 8-18,
and 20 (App. Br. 2). Examiner entered rejections under 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify the Real Party in Interest as Roche Diagnostics
International AG (App. Br. 1 ).
Appeal2014-009039
Application 12/969,664
STATEMENT OF THE CASE
Appellants' invention relates to "ambulatory insulin infusion systems
and, more specifically, to ambulatory insulin infusion systems as used in the
therapy of Diabetes Mellitus by continuous subcutaneous insulin infusion"
(Spec. i-f 2). Independent claims 1, 16, and 17 are representative and
reproduced in the Claims Appendix of Appellants' Appeal Brief.
Claims 1---6, 8-13, and 16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Mann2 and Harel. 3
Claims 14, 15, 17, 18, and 20 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Mann, Harel, and Talbot.4
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants' Specification discloses
The phrase "therapeutically significant delay interval"
refers to a delay interval that has a non-negligible impact on the
PwD's[5J blood glucose curve. That is, the resulting blood
glucose curve over time is significantly different as compared to
an administration of the bolus without the delay interval. The
minimum length of a delay interval to be therapeutically
significant is typically on the order of minutes. The minimum
length may be dependent upon the PwD and the absorption
2 Mann et al., US 6,554,798 Bl, issued Apr. 29, 2003.
3 Harel et al., US 2007/0156177 Al, published July 5, 2007.
4 Talbot et al., US 7,344,500 B2, published Mar. 18, 2008.
5 Appellants define the acronym "PwD" as "a Person with Diabetes" (Spec.
,-r 3).
2
Appeal2014-009039
Application 12/969,664
characteristics of the insulin formulation. A delay on the order
of seconds such as, for example, the delay between the
programming of a bolus by the PwD and the beginning of its
administration, is not considered as therapeutically significant as
a delay on the order of minutes.
(Spec. if 29.)
FF 2. Examiner finds that Mann discloses the subject matter of Appellants'
claimed invention with the exception of the delivery of a "bolus upon the
expir[ation] of a therapeutically significant delay interval" (Ans. 3).
FF 3. Harel discloses
If the glucose level is over 500 [] emergency measures
may be required, for example alerting the patient or his physician
[] and dumping all available insulin in the pancreas []. A store
of available insulin may be maintained in the pancreas or in
device [] (or an associated insulin pump) for just these cases.
(Harel if 303; see also Ans. 3.)
FF 4. Examiner relies on Talbot to "disclose[] sensor measurements taking
place often and regularly [] for both display purposes and changing a
regimen" and "automatically adjusting a regimen if the patient's measured
glucose level drifts outside the normal range" (Ans. 5---6).
ANALYSIS
The system of Appellants' claim 1 comprises, inter alia, a "delay
module [that] triggers administration of [a] bolus automatically by the
administration module upon [the expiration] of a therapeutically significant
delay interval started by the delay module after the data is collected by the
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Appeal2014-009039
Application 12/969,664
data collection module" (see Appellants' claim 1 ). The system of
Appellants' claim 16 comprises, inter alia,
a delay module [] configured to start automatically a
therapeutically significant delay interval after collecting the data
by the data collection module, wherein the delay module triggers
the administration of the bolus and the data collection module
collects further data relevant for the bolus amount after the
therapeutically significant delay interval ends, and the delay
module also triggers the administration of the bolus by the
administration module upon receipt of an acknowledgement user
input during the therapeutically significant delay interval.
(Appellants' claim 16.) The method of Appellants' claim 17 comprises,
inter alia, the steps of "starting automatically a therapeutically significant
delay interval after [a] blood glucose value is collected via a delay module"
and "administering [] the bolus amount of insulin, automatically, upon one
of: after the therapeutically significant delay interval expires, and receipt of
an acknowledgement [from] user input during the therapeutically significant
delay interval" (see Appellants' claim 17).
The combination of Mann and Hare!:
Based on the combination of Mann and Harel, Examiner concludes
that, at the time of Appellants' invention was made, it would have been
prima facie obvious to "modify the device of Mann to alert a physician and
automatically deliver a treatment as calculated by the bolus estimator in an
emergency situation as taught by Harel to prevent a patient from dying from
lack of insulin if they cannot use the controller" (Ans. 3). We are not
persuaded.
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Appeal2014-009039
Application 12/969,664
As Appellants explain, their claimed invention requires that "a
therapeutically significant delay interval [is] started by the delay module
after the data is collected by the data collection module" (Reply Br. 2).
Examiner finds that Mann fails to disclose the delivery of a "bolus upon the
expir[ation] of a therapeutically significant delay interval" (FF 2). Further,
notwithstanding Examiner's assertion to the contrary, Harel fails to make up
for the foregoing deficiency in Mann (see Ans. 2--4 and 8). As Appellants
explain, while "Harel has an emergency module, [] there is no delay interval
between collection of data and acting on that data" (Reply Br. 2; see FF 2).
To the contrary, Appellants contend that Harel collects data "and then
immediately reacts to [that data] without any therapeutically significant
delay interval" (Reply Br. 2; FF 2). In this regard, Appellants contend that
any delay that may occur between the collection of data points in Harel is
reset each time Harel collects a new data point and when a data point is
collected in Harel that would relate to the release of a bolus, the bolus is
released immediately without a therapeutically significant delay as required
by Appellants' claimed invention (see Reply Br. 2-3; cf Ans. 8 ("The
therapeutically significant delay of Harel is the time Harel monitors the
glucose level and does nothing while the glucose level is normal or
approaches the emergency threshold. Such a delay expires upon reaching
the threshold after which emergency action is taken")).
In sum, Examiner failed to establish an evidentiary basis on this
record to support a conclusion that the combination of Mann and Harel
suggests a system that comprises a delay module that triggers administration
of a bolus automatically by the administration module upon the expiration of
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Appeal2014-009039
Application 12/969,664
a therapeutically significant delay interval, which is started by the delay
module after the data is collected by the data collection module as is
required by Appellants' claimed invention.
The combination of Mann, Hare!, and Talbot:
Based on the combination of Mann, Harel, and Talbot, Examiner
concludes that, at the time Appellants' invention was made, it would have
been obvious to
modify the method of Mann to automatically deliver the bolus
even if confirmation is not received ifthe patient's glucose level
is dangerously abnormal as taught by Talbot so that an
incapacitated user will still receive a minimal treatment (it is
known within the art that being too far outside the proper glucose
range is life-threatening).
(Ans. 6.) We are not persuaded. Examiner failed to establish that Talbot,
makes up for the deficiency in the combination of Mann and Harel as
discussed above (see generally App. Br. 17-20; see also FF 4).
CONCLUSION OF LAW
The preponderance of the evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1---6, 8-13, and 16 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Mann and Harel is reversed.
The rejection of claims 14, 15, 17, 18, and 20 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Mann, Harel, and Talbot is
reversed.
REVERSED
6